Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children

This study has been completed.

Sponsor:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT00528957

First Posted: September 14, 2007

Last Update Posted: October 6, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this study is to assess the safety and efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.

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Ages Eligible for Study:

2 Years to 11 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Major Inclusion Criteria:

Documented laboratory diagnosis of HIV-1 infection

Plasma HIV-1 RNA < 400 copies/mL

Currently on a stable stavudine or zidovudine -containing antiretroviral therapy regimen for at least 12 weeks

Naive to tenofovir DF

Key Inclusion Criteria for the First 96-Week Extension

Completed 48 weeks of treatment in Arm 1 or Arm 2 of the study

<18 years of age (at the start of the extension)

Participants initially randomized to Arm 2 will be given the option to replace stavudine or zidovudine with tenofovir DF in the 96-week extension at the investigator's discretion, if the investigator determines that tenofovir DF is safe and beneficial for the participant.

Key Inclusion Criteria for the Second and Third 96-Week Extension and Fourth Open-Ended Extension

Completed of treatment with study drug in the first extension phase

<18 years of age at the start of the extension. This inclusion criterion is not applicable in those regions where tenofovir DF is not commercially available for treatment of HIV-1 infection in adults.

Key Exclusion Criteria:

Participants receiving ongoing therapy with any of the following

Nephrotoxic agents

Systemic chemotherapeutic agents

Systemic corticosteroids

Interleukin 2 (IL 2) and other immunomodulating agents

Investigational agents

Pregnant or lactating participants

Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication

Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance